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SIM0718 Treatment of Asthma Clinical Study

ConditionAsthma; Eosinophilic
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12-75
SponsorSimcere Pharmaceutical Co., Ltd

About this trial

Phase III clinical study of SIM0718 asthma

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 12 to 75 years, weight ≥ 40 kg, diagnosed with asthma for at least 12 months；

Currently receiving medium- to high-dose inhaled corticosteroids (ICS) in combination with 1 or 2 control medications and have been on a stable dose for at least 28 days prior to randomization；

Pre-bronchodilator (trough) FEV1 ≤ 80% of predicted normal for adults and ≤90% of predicted normal for adolescents ；

Positive bronchodilator response within 12 months prior to randomization or during the screening period;

Disqualifiers

Current respiratory disease that may impair lung function as judged by the investigator;

Diagnosis of helminth parasitic infection within 24 weeks prior to randomization and who have not received or have not responded to standard therapy;

Within 28 days prior to randomization, with acute or chronic infection; or have a severe viral infection;

Has a known or suspected history of immunosuppression or frequent, recurrent, or long-term infection;

Trial design

Design model

Parallel

Treatments tested in this trial

  • SIM0718 injection

    Drug

    Dosage form: injection Specification: 300mg/2ml/bottle Dosage: A loading dose of 600 mg is injected subcutaneously on day 1, followed by 300 mg SIM0718 subcutaneously every two weeks. Duration of medication: 52 weeks

  • SIM0718 injection of placebo

    Drug

    Dosage form: injection Specification: 2ml/bottle Dosage: 4ml subcutaneously on day 1, followed by 2ml of placebo subcutaneously every two weeks. Duration of medication: 52 weeks

Treatment groups

418 Participants
are divided into 2 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: SIM0718 injectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Annualized rate of severe asthma exacerbation events

Annualized rate of severe asthma exacerbation events within 52 weeks

Time frame
52 weeks

Secondary outcomes

1

Change from baseline in forced expiratory volume in the first second before bronchodilator use

Change from baseline in forced expiratory volume in the first second before within 12 weeks

Time frame
12 weeks
2

Change from baseline in Forced Vital Capacity (FVC)

Change from baseline in Forced Vital Capacity (FVC) of during the 52-week treatment period

Time frame
During the 52-week treatment period
3

Change from baseline in pre-bronchodilator forced expiratory volume in 1 second

Change from baseline in pre-bronchodilator forced expiratory volume in 1 second of during the 52-week treatment period

Time frame
During the 52-week treatment period
4

Change from baseline in Peak Expiratory Flow (PEF)

Change from baseline in Peak Expiratory Flow (PEF) of during the 52-week treatment period

Time frame
During the 52-week treatment period

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Simcere Pharmaceutical Co., Ltd

Lead sponsor

Source ClinicalTrials.gov
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